A Phase 3 interventional study of amino acid composition (asn01) and Placebo in Nervous System Disorder and Imbalance of Constituents of Food Intake, sponsored by Kyberg Vital GmbH. Completed at 1 site in Germany. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-09-07.
Sponsored by Kyberg Vital GmbH · Phase 3, Interventional, and Treatment
Psychosocial stress leads to altered neuroendocrine functions, such as serotonergic dysfunction, as well as alterations of the autonomic nervous system and the hypothalamic-pituitary-adrenal (HPA) axis activity resulting in an imbalance between inhibitory and excitatory neurotransmitters. Clinical consequences include, inter alia, neurovegetative disorders, higher resting heart rate, hypertension, depressive symptoms, sleep disturbances, irregular body-weight changes, and insulin resistance. Poor dietary intake of the essential amino acid L-tryptophane as a precursor to 5-hydroxytryptamine (HT, serotonin) increases sensitivity to stress.
It is therefore the investigators hypothesis that daily oral administration of an amino acid mixture (dosage 3.8 g/day) with micronutrients specifically designed to decrease neurovegetative disorders will target these neuroendocrine and metabolic alterations in adults with psychosocial stress. The principal endpoints will be a decrease in points in the psychological-neurological questionnaire (PNF).
985 studies on the registry are indexed under Nervous System Diseases; 251 are open to participants now.
This study's enrollment of 80 is above the median of 48 across 629 interventional studies indexed under Nervous System Diseases.
Browse Nervous System Diseases studies →Kyberg Vital GmbH is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Dietary supplement: specific amino acid composition with micronutrients
Dietary Supplement: amino acid composition (asn01)
Placebo contains no amino acids and no micronutrients and is identical in appearance and solution properties.
Other: Placebo
Amino acid composition with micronutrients, once a day (in the evening, 2 hours after dinner) content of a sachet mixed with 200 ml water. Duration: 12 weeks
Also known as: Brand name: aminoplus neurostress
Placebo; once a day (in the evening, 2 hours after dinner) content of a sachet mixed with 200 ml water. Placebo contains no amino acids and micronutrients and is identical in appearance and solution properties. Duration: 12 weeks
Psychological neurological questionnaire (PNF)
Pre-post intervention changes in total number of points PNF
Time frame: 12-week dietary intervention
Psychological neurological questionnaire (PNF)
Pre-post improvement in total number of points from the psychological-neurological questionnaire (PNF) about 10 Points or more
Time frame: 12-week dietary intervention
Salivary cortisol concentration (30 minutes after waking in the morning)
Absolute difference between cortisol concentration at baseline and 12 weeks
Time frame: 12-week dietary intervention
Salivary cortisol concentration (in the evening between 8 and 10 pm, 2 hours after dinner)
Absolute difference between cortisol concentration at baseline and 12 weeks
Time frame: 12-week dietary intervention
Serotonin concentration in blood
Absolute difference between serotonin concentration at baseline and 12 weeks
Time frame: 12-week dietary intervention
The record gives a start of Mar 2011, a primary completion of May 2012 and a completion of Jun 2012. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
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Kyberg Vital GmbH